Aurix Sound Stimulator

GUDID 00627908080028

Sound stimulator for use with the Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Vivosonic Inc

Evoked-potential audiometer

• Primary Device ID: 00627908080028
• NIH Device Record Key: 7727ea44-2126-401a-a3bf-4618fcc1305d
• Commercial Distribution Discontinuation: 2020-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aurix Sound Stimulator
• Version Model Number: 11002
• Company DUNS: 201740425
• Company Name: Vivosonic Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627908080028 [Primary]

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-21
• Device Publish Date: 2016-09-23

On-Brand Devices [Aurix Sound Stimulator ]

• 00062790880026: Sound stimulator for use with the Aurix system (DI: 00062790880019). The UDI is comprised of:
• 00627908080028: Sound stimulator for use with the Aurix system (DI: 00627908080011). The UDI is comprised of: